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Opportunity for exploring anti-PD-L1 and anti-PD-1 agents in combination with targeted therapies

A group of Italian and Swiss researchers have found a correlation between PD-L1 expression and EGFR mutation, as well as between PD-1 expression and KRAS mutations in a cohort of molecularly selected patients with non-small-cell lung cancer (NSCLC). Their findings support a rationale for investigating anti-PD-L1 and anti-PD-1 agents in combination with targeted therapies. The results were presented by Dr Armida D’Incecco of the Department of Medical Oncology, Istituto Toscano Tumori in Livorno, Italy in a proffered papers session at the 4th European Lung Cancer Conference (26-29 March 2014, Geneva, Switzerland).

The programmed death 1 (PD-1) receptor is an inhibitory T cell receptor with two known ligands, programmed death ligand 1 and 2 (PD-L1 and PD-L2). In this study, the researchers evaluated PD-L1 and PD-1 expression in a cohort of 125 NSCLC patients.

PD-L1 and PD-1 expression was assessed by immunohistochemistry, considering as positive a staining intensity ≥ 2 in more than 5% of cells.

PD-L1 was successfully evaluated in 123 samples. PD-L1 positive expression was observed in 68 (54.4%) cases. The researchers found that PD-L1 positivity was significantly associated with presence of EGFR mutations (p < 0.0001), while no association was observed with other biomarkers.

PD-1 was assessed in 122 samples and PD-1 expression was demonstrated in 43 (34.4%) cases. PD-1 positive expression was significantly associated with KRAS mutated status (p = 0.005), while no association was observed with other biomarkers.

Although analysis was done in a small subset, the results are interesting and suggest a correlation between PD-L1 expression and EGFR mutation, as well as between PD-1 expression and KRAS mutations, supporting the idea for further investigation of anti-PD-L1 or anti-PD-1 agents in combination with targeted therapies.

Dr Fred Hirsch, who discussed the study results, believes that PD-L1/PD-1 immunohistochemistry needs validation, as no assay is fully validated yet. In addition, he presented PD-L1 expression and driver mutation “map” in NSCLC - a knowledge derived and modified upon Kowanetz M et al. presentation at 2013 World Conference on Lung Cancer.

In lung adenocarcinoma, approximately 47% of the immune infiltrate is PD-L1. Approximately 70% of these PD-L1 positive tumours are also MET positive, KRAS mutant or EGFR mutant. Further, PD-L1 positive NSCLC also expresses other immune checkpoints such as TIM3, LAG-3, B7-H3, B7-H4, and CTLA-4.

Dr Hirsch concluded that the study of D’Incecco and colleagues opens an interesting hypothesis if PD-L1 and PD-1 expressing tumours are two different diseases.